1.Correlation between the serum ferritin levels and disease activity of patients with systemic lupus erythematosus
Yongtong CAO ; Ping WANG ; Qianzi ZHAO ; Jinghua LI ; Tie ZHANG
Chinese Journal of Laboratory Medicine 2014;37(4):294-297
Objective To investigate the relationship between the serum ferritin levels and disease activity of patients with systemic lupus erythematosus (SLE).Methods One hundred and forty-six patients with SLE and 65 healthy volunteers were involved.Serum ferritin,C-reactive protein (CRP),erythrocyte sedimentation rate (ESR) and anti-double-stranded DNA antibodies (dsDNA) were measured in two groups.The activity of SLE was evaluated by systemic lupus erythematosus disease activity index (SLEDAI) score.The data were recorded and analyzed.SPSS 19.0.statistical software was used in statistical analysis.Analysis of variance was employed in comparison between groups using,t test was used in further pairwise comparisons,Pearson correlation test was adopted to evaluate the correlation between two groups.Results The level of serum ferritin in patients with SLE group was significantly higher than that of control group (505.4 ±408.9) ng/ml and (72.4 ±42.8) ng/ml,respectively,t =6.67,P <0.01.57.5% (84/146) patients with SLE had elevated serum ferritin.Patients with high SLEDAI scores had significantly higher ferritin concentrations than other patients (807.6 ± 412.3) ng/ml and (96.0 ± 44.7) ng/ml,t =6.56,P <0.01.The levels of serum ferritin in SLE patients were positively correlated with SLEDAI score and serum CRP (r =0.396,P < 0.01 ; r =0.351,P < 0.01),and it was not related with ESR or dsDNA (r =0.111,P=0.09;r =0.078,P =0.23).Conclusion The level of serum ferritin could reflect the disease activity of patients with SLE,and it might be used as a new biomarker for disease activity of patients with systemic lupus erythematosus.
2.Correlations of estradiol and testosterone in hyperuricemia patients
Yongtong CAO ; Jiang LI ; Qianzi ZHAO ; Jinghua LI ; Tie ZHANG
Chinese Journal of Laboratory Medicine 2013;36(12):1131-1133
Objective To evaluate the serum concentrations of estradiol and testosterone in hyperuricemia patients and possible correlations of the two factors and uric acid (UA) in hyperuricemia (HUA) patients.Methods This was a case control study.We involved 90 hyperuricemia patients,103 healthy controls.Estradiol,testosterone,UA,serum glucose,lipid profile,creatinine and body mass index (BMI) were estimated in two groups.The statistical analysis of the data were performed using SPSS version 19.0 software.The estradiol,testosterone,UA,serum glucose,lipid profile,serum creatinine and BMI levels between the two groups were compared using the Student's t-test.Pearson correlation test was used to assess the correlation between serum UA levels and these indexes.Results Serum levels of estradiol in healthy subjects and hyperuricemia patients were 82.2 (55.6-108.8) pmol/L,65.8 (36.6-95.0) pmol/L respectively ;the serum levels of UA were 300.8(207.2-394.4) μmol/L,426.9(370.1-483.7) μmol/L,respectively.The levels of estradiol were higher in the healthy control group than those in the hyperuricemia group.There were significant differences of estradiol levels between these two groups (P < 0.05).Estradiol was negatively correlated with UA (r =-0.319,P < 0.01),so was testosterone (r =-0.312,P < 0.01).Conclusion The findings of the present study suggest that in hyperuricemia patients,there are associations between estradiol and UA and the levels of serum estradiol might be used as biomarkers in hyperuricemia.
3.Population bioequivalence statistical method based on earth mover′s distance for evaluation of particle size distribution consistency of ophthalmic emulsion
Qianzi XU ; Yueru LIANG ; Zhongwei ZHAO ; Yan. SHEN
Journal of China Pharmaceutical University 2022;53(6):698-704
Population bioequivalence (PBE) is a statistical approach recommended by FDA to evaluate the consistency of particle size distribution of numerous nanoparticle products.However, when particle size distribution (PSD) profile exhibits multiple peaks or other complex distributions, the traditional descriptors D50 and SPAN are no longer suitable to describe PSD.Earth mover''s distance (EMD) is a new statistical metric for assessing the difference between distributions.In this study, we used EMD to measure the discrepancy between PSD and then PBE was applied to perform statistical test to establish equivalence.Our results showed that the proposed method can effectively reject an unequivalent product and pass an equivalent product, thus indicating its helpfulness in guiding the optimization of formulation and preparation process.
4.The research of myosin-binding protein C in duced autoimmune myositis model
Yinli ZHANG ; Hang ZHOU ; Qinglin PENG ; Liguo YIN ; Xiaoming SHU ; Sigong ZHANG ; Xin LU ; Qianzi ZHAO ; Guochun WANG
Chinese Journal of Rheumatology 2015;(6):369-373
Objective To establish a new murine model of experimental autoimmune myositis by immunizing with MYBPC2 protein. Methods The purified Myosin-binding protein C, fast type (MYBPC2) was emulsified with complete Freundˊs adjuvant, then C57BL/6 mice were immunized by multi-point subcutaneous injection (0, 7 days), and intraperitoneal injection of pertussis toxin 2 μg simultaneously. The pathological changes of mice with different immunizing dose at the preconceived time were ex-plored. Mean-while, mice were immunized with 600 μg each time, and the muscle endurance was tested on the 21th day. The expression of major histocompatibility complex (MHC) class-Ⅰ and the surface biomarkers of the inflammatory cells in muscle tissues were observed. Mann-Whitney U test was used for statistical analysis. Results ① With the increase of immunizing dosage, muscle damage and inflammation tended to be more serious. On the 21th and 28th day, muscle lesions were most significant. Muscle fiber degeneration and necrosis and inflammatory cell infiltration could be seen in the experimental group. ② Compared with the control group, muscle endurance of mice in the experimental group decreased significantly [(6.1 ±1.3) min versus (9.2±1.6) min, U=2.00, P=0.017]. The MHC class-Ⅰ on the muscle fiber surface of the experimental group was positive, scattered infiltration of CD4 +, CD8+ T ly-mphocytes and CD68 + macrophages between muscle fibers and around the vascular areas could be observed, and CD20+B lymphocytes mainly distributed in the area around the blood vessels, nevertheless rarely seen between muscle fibers. Conclusion Exper-imental autoimmune myositis models of mice have been successfully induced by immunizing with MYBPC2 in China for the first time, and similar clinical and pathological features of human polymyositis could be observed. This new model can be used for studying the pathogenesis of autoimmune myositis.
5.Clinical characteristics and pathogenesis of sleep disorder in patients with post-traumatic stress disorder
Xinxin ZHAO ; Min CAI ; Qianzi YANG ; Hailong DONG
Chinese Journal of Behavioral Medicine and Brain Science 2021;30(11):1045-1050
Post-traumatic stress disorder(PTSD) caused by various natural disasters and man-made events has gradually become the highlight of neuroscientists. Sleep disorders after PTSD can impair the effect of treatment and affect the patient's prognosis. In addition, treatment for sleep problems can be effective in improving outcomes for people with PTSD, which indicates that it is significant to pay attention to sleep disorders after PTSD. However, current studies have focused more on the incidence of PTSD and severity of related symptoms after a traumatic event, and less on the occurrence and mechanism of sleep disorders after PTSD. A number of articles on stress and sleep disorders published in recent years provide reliable clues to understand the probable mechanisms of sleep disorders after PTSD. After summarizing the latest research results, this article finds that the occurrence of sleep disorder after PTSD may be related to the changes of connectivity between insula, hippocampus and medial-prefrontal cortex. Apart from that, decline in the mean phase difference of slow spindles in PTSD patients may reflect pathological changes in the thalamic cortical circuit, which may contribute to the objective diagnosis of PTSD and the development of sleep-focused interventions. This paper provides a systematic review of changes in sleep characteristics and possible neural circuitry mechanisms after PTSD from clinical and basic perspectives, which may provide potential directions for future researches on the pathological mechanism of sleep disorders after PTSD and screening novel intervention targets.
6. Lateral Hypothalamic Area Glutamatergic Neurons and Their Projections to the Lateral Habenula Modulate the Anesthetic Potency of Isoflurane in Mice
Shiyi ZHAO ; Rui LI ; Huiming LI ; Sa WANG ; Xinxin ZHANG ; Dan WANG ; Juan GUO ; Huihui LI ; Ao LI ; Tingting TONG ; Haixing ZHONG ; Qianzi YANG ; Hailong DONG
Neuroscience Bulletin 2021;37(7):934-946
The lateral hypothalamic area (LHA) plays a pivotal role in regulating consciousness transition, in which orexinergic neurons, GABAergic neurons, and melanin-concentrating hormone neurons are involved. Glutamatergic neurons have a large population in the LHA, but their anesthesia-related effect has not been explored. Here, we found that genetic ablation of LHA glutamatergic neurons shortened the induction time and prolonged the recovery time of isoflurane anesthesia in mice. In contrast, chemogenetic activation of LHA glutamatergic neurons increased the time to anesthesia and decreased the time to recovery. Optogenetic activation of LHA glutamatergic neurons during the maintenance of anesthesia reduced the burst suppression pattern of the electroencephalogram (EEG) and shifted EEG features to an arousal pattern. Photostimulation of LHA glutamatergic projections to the lateral habenula (LHb) also facilitated the emergence from anesthesia and the transition of anesthesia depth to a lighter level. Collectively, LHA glutamatergic neurons and their projections to the LHb regulate anesthetic potency and EEG features.
7.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
8.Interpretation of the Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine:weighting of evaluation indicators
Haili ZHANG ; Bin LIU ; Weili WANG ; Wenjie CAO ; Yijiu YANG ; Ziteng HU ; Yaxin CHEN ; Ning LIANG ; Huizhen LI ; Qianzi CHE ; Xingyu ZONG ; Zhao CHEN ; Yanping WANG ; Nannan SHI
China Pharmacy 2024;35(7):773-777
OBJECTIVE To provide a detailed report and interpretation of the method and results for determining the weights of the technical indicators from the “multi-dimensional and multi-criteria comprehensive evaluation index system (first edition)” stated in Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine. METHODS Normalization calculations were performed on the comprehensive weight values calculated by the analytic hierarchy process and expert weighting method to obtain the objective weights of the indicators. RESULTS The weight results of the six primary dimensions in the current comprehensive evaluation indicator system of Chinese patent medicine showed effectiveness dimension> safety dimension>standard dimension>application dimension>scientific dimension>economic dimension, with weight values of 0.281 0, 0.268 5, 0.195 8, 0.107 3, 0.096 1 and 0.051 3 respectively, consistent with the results of most researches currently. CONCLUSIONS The process of weight determination in this indicator system is scientifically reasonable, with clear methods and clear interpretations, and is worthy of further optimization and widespread application.
9.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 6): Formation and Presentation of Recommendations
Yujing ZHANG ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Fuqiang ZHANG ; Qianzi CHE ; Zhao CHEN ; Yuqi LIU ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):172-177
Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine (CPM), and should encompass the determination of the strength and direction of the recommendation, the rationale for the recommendation, and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs, the priority of the clinical questions, the pros and cons of efficacy and adverse effects, patient acceptance, the feasibility of the recommendation and the availability of resources, social fairness, economic benefits, and other influencing factors. In order to better guide guideline developers to consider these factors more rationally, this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.
10.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.